DUBLIN, Ireland, May 18, 2015 /PRNewswire/ -- Actavis plc
(NYSE: ACT) today announced that NAMZARIC™ (memantine hydrochloride
extended-release and donepezil hydrochloride), a once-daily,
fixed-dose combination of memantine hydrochloride extended-release
(a NMDA receptor antagonist), and donepezil hydrochloride (an
acetylcholinesterase inhibitor), is now available to patients and
healthcare professionals across the
United States. NAMZARIC was approved by the U.S. Food and
Drug Administration (FDA) in December for the treatment of moderate
to severe Alzheimer's disease in patients stabilized on memantine
hydrochloride and donepezil hydrochloride.
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"We're excited to make once-daily NAMZARIC available as another
treatment option for patients with moderate to severe Alzheimer's
disease," said Bill Meury, Actavis
President, Branded Pharma. "Since the launch of NAMENDA XR®
(memantine hydrochloride) in 2013, the two medications, NAMENDA XR
and donepezil, have been commonly prescribed in combination with
one another to treat the symptoms of moderate to severe Alzheimer's
disease. NAMZARIC offers an option with the benefits of both
treatments, while reducing the number of pills a patient and their
caregivers need to administer each day, to treat this disease."
"We are pleased that NAMZARIC is now available for patients who
face the challenges associated with moderate to severe Alzheimer's
disease," said Gregory T. Went,
Ph.D., Chairman and CEO of Adamas Pharmaceuticals, Inc. "Actavis
and Adamas have worked together to create this new fixed-dose
combination therapy, the second product from our collaboration. We
believe NAMZARIC provides patients and their caregivers with a much
needed and more convenient treatment option."
About NAMZARIC™
NAMZARIC is a once-daily,
fixed-dose combination of memantine hydrochloride extended-release,
a NMDA receptor antagonist, and donepezil hydrochloride, an
acetylcholinesterase inhibitor. NAMZARIC will be available in two
dosage strengths, 28/10 mg (memantine HCl
extended-release/donepezil HCl) and 14/10mg (memantine HCl
extended-release/donepezil HCl) for patients with severe renal
impairment. Memantine hydrochloride extended-release is the active
ingredient in the currently marketed NAMENDA XR®, which is
indicated for the treatment of moderate to severe dementia of the
Alzheimer's type. Donepezil is the active ingredient in ARICEPT®
(donepezil hydrochloride), which is indicated for the treatment of
mild to severe dementia of the Alzheimer's type. Actavis and Adamas
collaborated on the development of the fixed-dose combination and
Actavis will have exclusive U.S. commercialization rights, while
Adamas will retain exclusive commercialization rights outside of
the U.S.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
NAMZARIC is contraindicated in
patients with known hypersensitivity to memantine hydrochloride,
donepezil hydrochloride, piperidine derivatives, or to any
excipients used in the formulation.
WARNINGS AND PRECAUTIONS
- Anesthesia: NAMZARIC is likely to exaggerate
succinylcholine-type muscle relaxation during anesthesia.
- Cardiovascular Conditions: NAMZARIC may have vagotonic effects
on the sinoatrial and atrioventricular nodes manifesting as
bradycardia or heart block. Bradycardia or heart block may manifest
in patients both with and without known underlying cardiac
conduction abnormalities.
- Peptic Ulcer Disease and Gastrointestinal Bleeding: Patients
treated with NAMZARIC should be monitored closely for symptoms of
active or occult gastrointestinal bleeding, especially those at
increased risk for developing ulcers, those with a history of ulcer
disease, or those receiving concurrent nonsteroidal
anti-inflammatory drugs (NSAIDs).
- Nausea and Vomiting: NAMZARIC can cause diarrhea, nausea, and
vomiting, although in most cases these effects have been mild and
transient, and have resolved during continued treatment.
- Genitourinary Conditions: NAMZARIC may cause bladder outflow
obstructions. Conditions that raise urine pH may decrease the
urinary elimination of memantine resulting in increased plasma
levels of memantine.
- Seizures: Cholinomimetics, including donepezil hydrochloride,
are believed to have some potential to cause generalized
convulsions. However, seizure activity also may be a manifestation
of Alzheimer's disease.
- Pulmonary Conditions: Cholinesterase inhibitors should be
prescribed with care to patients with a history of asthma or
obstructive pulmonary disease.
ADVERSE REACTIONS
- The most common adverse reactions, occurring at a frequency of
at least 5% in patients taking memantine hydrochloride extended
release 28 mg/day, and greater than placebo, were headache (6% vs
5%), diarrhea (5% vs 4%), and dizziness (5% vs 1%).
- The most common adverse reactions, occurring at a frequency of
at least 5% in patients taking donepezil, and at twice or more the
rate of placebo, include diarrhea (10% vs 4%), anorexia (8% vs 4%),
vomiting (8% vs 4%), nausea (6% vs 2%), and ecchymosis (5% vs
2%).
DRUG INTERACTIONS
- Alterations of urine pH toward the alkaline condition may lead
to an accumulation of memantine with a possible increase in adverse
reactions. NAMZARIC should be used with caution under conditions
that may be associated with increased urine pH including
alterations by diet and the clinical state of the patient.
- The combined use of memantine hydrochloride with other NMDA
antagonists (amantadine, ketamine, and dextromethorphan) has not
been systematically evaluated and such use should be approached
with caution.
- Inhibitors of CYP450, 3A4 (e.g.,
ketoconazole) and 2D6 (e.g., quinidine), inhibit donepezil
metabolism in vitro. Whether there is a clinical effect of
quinidine is not known.
- Inducers of CYP3A4 (e.g., phenytoin, carbamazepine,
dexamethasone, rifampin, and phenobarbital) could increase the rate
of elimination of donepezil.
- Cholinesterase inhibitors, including donepezil hydrochloride,
have the potential to interfere with the activity of
anticholinergic medications.
DOSAGE AND ADMINISTRATION
- Patients stabilized on memantine hydrochloride (10 mg twice
daily or 28 mg extended-release once daily and donepezil
hydrochloride 10 mg) can be switched to NAMZARIC 28 mg/10 mg, taken
once a day in the evening. Patients should start NAMZARIC the day
following the last dose of memantine hydrochloride and donepezil
hydrochloride administered separately.
- Patients with severe renal impairment (creatinine clearance
5-29 mL/min, based on the Cockcroft-Gault equation), stabilized on
memantine hydrochloride (5 mg twice daily or 14 mg extended-release
once daily) and donepezil hydrochloride 10 mg, can be switched to
NAMZARIC 14 mg/10 mg, taken once daily.
About Alzheimer's
Alzheimer's disease is a
progressive, neurodegenerative disorder characterized by problems
with memory, thinking and behavior that eventually become severe
enough to affect daily tasks. An estimated 5.2 million people in
the United States are currently
living with Alzheimer's disease. Alzheimer's disease is the fifth
leading cause of death in the United
States among those aged 65 and older and was reported as an
underlying cause of death for more than 83,000 Americans in
2010.
About Adamas Pharmaceuticals
Adamas Pharmaceuticals,
Inc. (Nasdaq: ADMS) is a specialty pharmaceutical company driven to
improve the lives of those affected by chronic disorders of the
central nervous system. Adamas is currently developing its lead
wholly-owned product candidate, ADS-5102, for a complication
associated with the treatment of Parkinson's disease known as
levodopa-induced dyskinesia, or LID, and is evaluating other
potential indications. The company's portfolio also includes two
approved products with Forest Laboratories Holdings Limited (a
subsidiary of Actavis plc), Namzaric™ and Namenda XR®. Forest is
responsible for marketing both products in the United States under an exclusive license
from Adamas. For more information, please visit
www.adamaspharma.com.
About Actavis
Actavis plc (NYSE: ACT), headquartered
in Dublin, Ireland, is a unique,
global pharmaceutical company and a leader in a new industry model
– Growth Pharma. Actavis is focused on developing,
manufacturing and commercializing innovative branded
pharmaceuticals, high quality generic and over-the-counter
medicines and biologic products for patients around the
world. In March 2015, Actavis
plc acquired Allergan.
Actavis markets a portfolio of best-in-class products that
provide valuable treatments for the central nervous system, eye
care, medical aesthetics, gastroenterology, women's health,
urology, cardiovascular and anti-infective therapeutic categories,
and operates the world's third-largest global generics business,
providing patients around the globe with increased access to
affordable, high-quality medicines. Actavis is an industry leader
in research and development, with one of the broadest development
pipelines in the pharmaceutical industry and a leading position in
the submission of generic product applications globally.
With commercial operations in approximately 100 countries,
Actavis is committed to working with physicians, healthcare
providers and patients to deliver innovative and meaningful
treatments that help people around the world live longer, healthier
lives.
Actavis intends to adopt a new global name – Allergan – pending
shareholder approval in 2015.
For more information, visit Actavis' website at
www.actavis.com.
Forward-Looking Statement
Statements contained in this
press release that refer to future events or other non-historical
facts are forward-looking statements that reflect Actavis' current
perspective of existing trends and information as of the date of
this release. Except as expressly required by law, Actavis
disclaims any intent or obligation to update these forward-looking
statements. Actual results may differ materially from Actavis'
current expectations depending upon a number of factors affecting
Actavis' business. These factors include, among others, the
difficulty of predicting the timing or outcome of FDA approvals or
actions, if any; the impact of competitive products and pricing;
market acceptance of and continued demand for Actavis' products;
risks associated with acquisitions, mergers and joint ventures;
difficulties or delays in manufacturing; and other risks and
uncertainties detailed in Actavis' periodic public filings with the
Securities and Exchange Commission, including but not limited to
Actavis' Quarterly Report on Form 10-Q for the quarter ended
March 31, 2015. Except as expressly
required by law, Actavis disclaims any intent or obligation to
update these forward-looking statements.
ACTAVIS CONTACTS: Investors:
Lisa DeFrancesco
(862) 261-7152
Media:
David Belian
(862) 261-8141
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SOURCE Actavis plc